DeviceClearance

ERBECRYO 2 Cryosurgical Unit +4 more— 510(k) K190651

Substantially Equivalent

Erbe Elektromedizin GmbH

FDA 510(k) clearance K190651 for ERBECRYO 2 Cryosurgical Unit +4 more, Substantially Equivalent on 2020-01-07. Applicant: Erbe Elektromedizin GmbH. Device class: 2.

Clearance details

Device name as filed
ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter
Applicant
Erbe Elektromedizin GmbH
Product code
Code GEH
Device class
Class 2
Regulation
21 CFR 878.4350
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tuebingen, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEH

product code GEH
Death
25
Injury
351
Malfunction
901
Total
1,277

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K190651

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190651.

Data sourced from openFDA. This site is unofficial and independent of the FDA.